This study evaluates the role of colchicine in the prevention of atrial fibrillation in patients undergoing open heart surgery. Half of participants will receive colchicine and the other half will not
Atrial fibrillation (AF) is the most common arrhythmia in patients undergoing cardiac surgery and is estimated to occur in 26% of all cardiac surgery patients. It can lead to increase morbidity, mainly due to hemodynamic instability and thromboembolic complications, and to increased hospital stay with its associated higher health care cost. Previous studies have demonstrated that increased inflammation may precede AF and, therefore, interventions that reduce the inflammatory process may help reduce the incidence of AF. Colchicine has potent anti-inflammatory properties and may therefore be capable of reducing the incidence of AF. This study aims to determine whether the administration of colchicine starting the day before cardiac surgery and continuing until discharge may lead to reduction in post-operative AF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
360
colchicine given as per trial protocol
The Number of Participants With Atrial Fibrillation
The primary efficacy end point was the rate of AF in both arms. AF lasting more than 5 minutes were considered significant
Time frame: From date of randomization until the date of discharge, assessed up to 2 weeks
The Number of Participants With Colchicine Side Effects
The primary safety endpoint was the occurrence of side effects. Side effects monitored were mainly gastrointestinal effects (especially diarrhoea), alopecia, anorexia, hepatotoxicity, myotoxicity, and bone marrow toxicity.
Time frame: From date of randomization until the date of discharge, assessed up to 2 weeks
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